Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee.

  • Great Britain. Parliament. House of Commons. Select Committee on Science and Technology.
Date:
2006
Catalogue details

Licence: Open Government Licence

Credit: Watching the directives : scientific advice on the EU Physical Agents (Electromagnetic Fields) Directive : fourth report of session 2005-06 : report, together with formal minutes, oral and written evidence / House of Commons, Science and Technology Committee. Source: Wellcome Collection.

    112/144 (page 50)
    will investigate these supposed deficiencies and provide further evidence for any future revision or confirmation of the directive. In the mean time we understand that the directive will be implemented as it stands. The implementation notwithstanding, perhaps a consultation process and involvement of all stakeholders at the earliest stage would have led to a smoother implementation of new policies and regulations. January 2006 APPENDIX 9 Memorandum from the Wellcome Trust 1. The Wellcome Trust welcomes the opportunity to respond to the questions raised by the House of Commons Select Committee on Science and Technology in its inquiry on the handling of scientific advice, risk and evidence. This response will focus mainly on the case study identified by the Committee: “The use of MRI equipment: the EU Physical Agents (Electromagnetic Fields) Directive”, but will also make some general comments about the use of scientific advice from the Trust’s perspective. 2. The Wellcome Trust is an independent research-funding charity, established under the will of Sir Henry Wellcome in 1936. It is funded from a private endowment, which is managed with long-term stability and growth in mind. The Trust’s mission is “to foster and promote research with the aim of improving human and animal health”. One way the Trust works to meet its mission is by stimulating an informed dialogue to raise awareness and understanding of biomedical science, its achievements, applications and implications. The Trust also seeks to provide the best available evidence and information in order to ensure that there is a good balance between the needs of research and those of society. 3. We argue that the UK Government must ensure that the process for seeking scientific advice is as - comprehensive for the development of European legislation as it is for UK policy. Specific points made in this response include: — the need to develop effective methods to alert all relevant stakeholders to EU consultations; — the need to improve mechanisms of communication about EU policy decisions, for example the Government should create a web portal to provide information about the progress of EU decisions; — the importance of the best available evidence informing policy-making; and — the need to use a proportionate and consistent approach for the analysis of risks. BACKGROUND TO THE EU PHysICAL AGENTS (EMF) DIRECTIVE 4. The Physical Agents (Electromagnetic Fields) Directive 2004/40/EC was published by the EU in 2004, and must be implemented into national law by Member States by 30 April 2008. There are concerns that the Directive could have serious consequences for the use of magnetic resonance imaging (MRI), both in the clinic and for research purposes. 5. The Directive defines maximum exposure levels for electromagnetic fields (EMF) to protect workers from risks to their health and safety. This will apply to all operating staff and those maintaining equipment, but not to patients. The exposure limits included in the Directive for gradient fields (100-1000 Hz) will prevent workers from standing close to the bore during imaging. This could prohibit interventional MRI (including neurosurgery, cardiac catheterisation and tumour ablation); limit the provision of patient care during investigations, for patients under general anaesthetic, children or psychiatric patients; and restrict practical maintenance and routine cleaning. The use of new, more powerful high-field scanners in clinical research will be particularly limited, and the development of new MRI methodologies and improvements in technology—a particular strength of research in the UK—may be threatened. 6. In draft stages, the Directive included a limit for exposure to static fields (0 Hz), which would have had a significant impact on all uses of MRI equipment. This limit was subsequently removed from the Directive during negotiations, mainly as a result of lobbying by industry and manufacturers, co-ordinated through COCIR (the European Coordination Committee of the Radiological, Electromedical and Medical Information Technology Industries). There is concern that static limits may be reinstated during implementation in the UK or in future reviews of the Directive. 7. It is not yet known how the/Directive will be implemented in the UK, although the UK Government has now realised the implications and the “unintended consequences” for the MR community. The impact of the Directive was raised in a debate in the House of Lords on 25 October when Lord Hunt of King’s Heath expressed concerns. The Health and Safety Executive (HSE), responsible for transposing the Directive, held a roundtable discussion meeting in January 2006 with key stakeholders to consider the implications for MRI users, and will also consult on the proposed regulations in Summer 2006.